Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Capecitabine

Lapatinib

Antimetabolites

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

pyrotinib(400 mg once daily) + capecitabine (2000 mg/m\^2 daily, 1000 mg/ m\^2 BID)

Pyrotinib Plus Capecitabine

Lapatinib (1250 mg once daily)+ capecitabine (2000 mg/m\^2 daily, 1000 mg/m\^2 BID)

Lapatinib Plus Capecitabine

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine versus Lapatinib plus capecitabine in HER2+ MBC patients, who have prior received taxane and trastuzumab.Patients will be randomized in a 1:1 ratio to one of the following treatment arms.Arm A: pyrotinib (400 mg once daily) + capecitabine (1000 mg/m\^2 twice daily),Arm B: Lapatinib (1250 mg once daily) + capecitabine (1000 mg/m\^2 twice daily).Patients will receive either arm of therapy until disease progression, unacceptable toxicity, or withdrawalof consent.

Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)

A Randomised, Open-label, Parallel Controlled, Multicentre, Phase 3 Clinical Trial of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer:

From infromed consent to progression or death

Jiangsu HengRui Medicine Co., Ltd.

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Pyrotinib:400mg/d,q.d.,p.o. A course of treatment need 21days. Capecitabine:1000mg/m2,bid,from day1-day14, A course of treatment need 21 days.

Pyrotinib plus Capecitabine

Min Yan

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study of pyrotinib plus capecitabine as the Therapy of brain metastases from HER2-positive metastatic breast cancer.

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. In the case of solitary brain metastases, surgery or stereotactic radiosurgery are the preferred therapeutic approaches.Chemotherapy is used after further progression of disease but it has limited effectiveness. In HER2-positive tumours, trastuzumab therapy has been postulated to be associated with an increased risk of development of brain metastases.Thus new therapeutic options are urgently needed to improve patients'outcome. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the possibility of pyrotinib plus capecitabine for brain metastases from HER2-positive metastatic breast cancer.

A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Single-arm, Open-label, Ahead Study

Individual participant data that underlie the results reported in this article, after de-identificationare available following article publication.

the proportion of patients with the best intracranial response of confirmed complete or partial response according to RECIST 1·1, as assessed by the investigator

time from the first dose to disease progression or any-cause death

proportion of patients with confirmed extracranial complete or partial response per RECIST 1·1

time from the first documented intracranial objective response to intracranial or extracranial disease progression in patients with confirmed response

time from the first dose of study drug to any-cause death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)	NCT03080805	HER2 Positive M...	Pyrotinib Plus ... Lapatinib Plus ...	18 Years - 70 Years	Jiangsu HengRui Medicine Co., Ltd.
A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer	NCT03691051	HER2 Positive M...	Pyrotinib plus ...	18 Years -	Henan Cancer Hospital

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